Single-use handheld diagnostic test device, and an associated system and method for testing biological and environmental test samples

• US 9,945,837 B2
• Filed: 09/07/2016
• Issued: 04/17/2018
• Est. Priority Date: 08/29/2008
• Status: Active Grant

• Current Assignee: Fio Corporation
• Original Assignee: Fio Corporation
• Inventors: Dupoteau, Francois, Dekel, Shlomit
• Primary Examiner(s): XU, XIAOYUN
• Application Number:
  US15/258,423
• Publication Number:
  US 20160377593A1
• Time in Patent Office: 587 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/1171 based on the shapes or appearances of their bodies or parts thereof
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: A61B 5/1176 Recognition of faces
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10T 436/12 Condition responsive control

Abstract

In a single-use handheld diagnostic test device and an associated system and method, a biological and/or environmental test sample is received and reacted with reagents. The test device tests a single sample and includes a sensor to detect test data. The test device mates with, and transmits the test data to, an electronic device. A processor of the electronic device applies algorithms to the test data to generate highly sensitive and accurate quantitative test results. A presentation element of the electronic device presents the test results to a user. The test device is adapted for disposal, or for sterilization and re-use, after the electronic device receives the test data. The electronic device may be, for example, a mobile communications device, a personal digital assistant, a laptop computer, a navigation device, a digital audio player, a camera, or a gaming device.

Claims

1. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:

(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having;

(i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(ii) a test connection element; and

(b) an electronic device having;

(i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device;

(ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and

(iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results;

(c) a connectivity interface adapted to operatively connect the test connection element and the electronic connection element;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data; and

wherein the test device has onboard memory which electronically stores the quality control algorithm and the test data; and

wherein the processor of the electronic device operatively receives the test data and the quality control algorithm from the test device via the connectivity interface.

2. A system according to claim 1, further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device.

3. A system according to claim 2, wherein the identification element comprises a biometric identification element, preferably a fingerprint scanner, a retinal scanner, a microphone and voice recognition element, a camera and facial recognition element, and/or a genetic expression factor identification element.

4. A system according to claim 1, wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and Wherein the identification element automatically accesses the user identification data stored in the electronic device.

5. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:

(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having;

(i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(ii) a test connection element; and

(b) an electronic device having;

(i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device;

(ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and

(iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results;

(c) a connectivity interface adapted to operatively connect the test connection element and the electronic connection element;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data and the quality control algorithm from the test device;

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device;

wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and wherein the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results.

6. A system according to claim 5, wherein the presentation element comprises a display element, and the algorithms generate the quantitative test results and/or the presentation data for presentation from the display element in the form of one or more visually presentable (a) textual data, (b) graphical data, and/or (c) colored indicator light data.

7. A system according to claim 5,

wherein the test results are quantified as high, medium, and/or low results.

8. A system according to claim 5,

wherein the test results are quantified as a positive or negative result.

9. A system according to claim 5,

wherein the test results are quantified to provide a diagnosis selected from a test result database comprising a plurality of diagnoses, each associated with a quantified range and wherein the quantified test results for the selected diagnosis is within the quantified range.

10. A system according to claim 5,

wherein the electronic device has a battery, and wherein the test connection element of the test device receives power, via the electronic connection element, from the battery.

11. A system according to claim 5, wherein the electronic device comprises:

(a) a test reader device;

(b) a cellular telephone;

(c) a mobile communications device;

(d) a personal digital assistant;

(e) a desktop computer;

(f) a laptop computer;

(g) a navigation device;

(h) a digital audio player;

(i) a camera;

(i) a gaming device;

(k) a television; and

/or (l) a radio.

12. A system according to claim 5, wherein the electronic device comprises a networking electronic device and automatically transmits the test data, the quantitative test results and/or the presentation data for recordal in one or more remote laboratory and/or hospital information systems.

13. A system according to claim 5,

wherein the presentation data presented to the user comprises treatment and follow-up suggestion data based on the test results.

14. A single-use handheld diagnostic test device system, for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of data analysis and quality control algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:

(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents;

(b) a connectivity interface operatively connecting the test device and the electronic device; and

(c) a mating test connection element operatively connected with, and electronically transmitting the quality control algorithm and the test data to the electronic device via, the connectivity interface operatively connected to the electronic connection element;

such as to enable the processor to operatively apply the data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively apply the data analysis and quality control algorithms to the test data for generation of quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results; and

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic transmission of the test data to the electronic device via the connectivity interface; and

further comprising onboard memory which electronically stores at least one of the quality control algorithm and the test data; and

wherein the test connection element electronically transmits the quality control algorithm to the electronic connection element of the electronic device via the connectivity interface.

15. A device according to claim 14, further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element.

16. A device according to claim 15, wherein the identification element comprises a biometric identification element, preferably a fingerprint scanner, a retinal scanner, a microphone and voice recognition element, a camera and facial recognition element, and/or a genetic expression factor identification element.

17. A device according to claim 15, adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device.

18. A single-use handheld diagnostic test device for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of the data analysis and quality control algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:

(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents;

(b) a connectivity interface operatively connecting the test device and the electronic device; and

(c) a mating test connection element operatively connected with, and electronically transmitting at least one of the quality control algorithm and the test data to the electronic device via, the connectivity interface operatively connected to the electronic connection element;

such as to enable the processor to operatively apply the data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively apply the data analysis and quality control algorithms to the test data for generation of quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after electronic transmission of the test data and the quality control algorithm from the test device to the electronic device via the connectivity interface;

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element;

adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results.

19. A device according to claim 18, adapted for use with a display element as the presentation element, and wherein the algorithms are adapted to generate the quantitative test results and/or the presentation data for presentation from the display element in the form of one or more visually presentable (a) textual data, (b) graphical data, and/or (c) colored indicator light data.

20. A device according to claim 18, wherein the algorithms are adapted to quantify the test results as high, medium, and/or low results.

21. A device according to claim 18, wherein the algorithms are adapted to quantify the test results as a positive or negative result.

22. A device according to claim 18, wherein the algorithms are adapted to quantify the test results to provide a diagnosis selected from a test result database comprising a plurality of diagnoses, each associated with a quantified range and wherein the quantified test results for the selected diagnosis is within the quantified range.

23. A device according to claim 18, the device being adapted for use with a battery onboard the electronic device, wherein the test connection element of the test device receives power, via the connectivity interface operatively connected to the electronic connection element, from the battery.

24. A device according to claim 18, adapted for use with one or more of following as the electronic device:

(a) a test reader device;

(b) a cellular telephone;

(c) a mobile communications device;

(d) a personal digital assistant;

(e) a desktop computer;

(f) a laptop computer;

(g) a navigation device;

(h) a digital audio player;

(i) a camera;

(j) a gaming device;

(k) a television; and

/or (l) a radio.

25. A device according to claim 18, adapted for use with a networking electronic device as the electronic device, such as to enable the networking electronic device to automatically transmit the test data, the quantitative test results and/or the presentation data for recordal in one or more remote laboratory and/or hospital information systems.

26. A device according to claim 18, adapted for use with presentation data presented to the user which comprises treatment and follow-up suggestion data based on the test results.

27. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:

(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having;

(i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(ii) a test connection element; and

(b) an electronic device having;

(i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device;

(ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and

(iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data and the quality control algorithm from the test device;

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device;

wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and wherein the identification element automatically accesses the user identification data stored in the electronic device;

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results; and

wherein the test results are quantified as a positive or negative result.

28. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:

(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having;

(i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(ii) a test connection element; and

(b) an electronic device having;

(i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device;

(ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and

(iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data and the quality control algorithm from the test device;

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device;

wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and wherein the identification element automatically accesses the user identification data stored in the electronic device;

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results; and

wherein the test results are quantified to provide a diagnosis selected from a test result database comprising a plurality of diagnoses, each associated with a quantified range and wherein the quantified test results for the selected diagnosis is within the quantified range.

29. A single-use handheld diagnostic test device for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of the data analysis and quality control algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:

(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(b) a mating test connection element operatively connected with, and electronically transmitting at least one of the quality control algorithm and the test data to the electronic device via, the electronic connection element;

such as to enable the processor to operatively apply the data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively apply the data analysis and quality control algorithms to the test data for generation of quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after electronic transmission of the test data and the quality control algorithm from the test device to the electronic device;

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element;

adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results; and

wherein the algorithms are adapted to quantify the test results as a positive or negative result.

30. A single-use handheld diagnostic test device for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of the data analysis and quality control algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:

(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and

(b) a mating test connection element operatively connected with, and electronically transmitting at least one of the quality control algorithm and the test data to the electronic device via, the electronic connection element;

such as to enable the processor to operatively apply the data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively apply the data analysis and quality control algorithms to the test data for generation of quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results;

wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after electronic transmission of the test data and the quality control algorithm from the test device to the electronic device;

further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element;

adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device; and

adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results; and

wherein the algorithms are adapted to quantify the test results to provide a diagnosis selected from a test result database comprising a plurality of diagnoses, each associated with a quantified range and wherein the quantified test results for the selected diagnosis is within the quantified range.